Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Grayson Acrylic Formed Nasoalveolar Molding Appliances.

Cleft Lip and Palate Clinical Trial

Official title:

Short Term Efficiency of Presurgical Vacuum Formed Nasoalveolar Molding Aligners in Infants With Bilateral Cleft Lip and Palate Compared With Conventional Grayson Acrylic Formed Nasoalveolar Molding Appliances: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04966572
• Other study ID #: BCLP_ Grayson_ vacuum
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: Khadega Ali Al Khateeb, PhD
• Phone: 00201100739869
• Email: khadejaalkhateeb[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either presurgical vacuum-formed nasoalveolar molding aligners VF (NAM) or conventional Grayson acrylic formed nasoalveolar molding appliances in order to evaluate their effect on the maxillary arch.

Description:

The aim of this trial is to evaluate and compare the short-term effect of VF (NAM) aligners with conventional Grayson appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive presurgical vacuum-formed nasoalveolar molding aligners while the second group will receive conventional Grayson acrylic formed nasoalveolar molding appliances. The follow-up period will be 4-6 months till surgical lip closure. The changes in the maxillary arch will be assessed by digital maxillary models.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 30, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• Non-syndromic Infants with complete BCLP infants

• Infants less than 1 month of age

• Males and females.

• Infants with displaced premaxilla

• Patients whose parents provided written consent for the study.

Exclusion Criteria:

• Patients above 1 month of age

• Syndromic and systemically ill infants.

• Patients with unilateral cleft lip and palate.

• Incomplete Cleft lip.

• Medically compromised patients

• Patient's/guardians who will be unwilling to go through the PNAM therapy

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• Presurgical vacuum formed nasoalveolar molding aligners
at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.
• Conventional Grayson acrylic formed nasoalveolar molding appliances
at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance. When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the maxillary arch	they will be measured in mm by digital models	T1 and T2 (4- 6 months)